Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13871 |
| Brand Name: | Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation) |
| Model: | Item number: 09000 |
| Affected: | Lot Number: 03.043/03.052/03.0.59 |
| Software version: | |
| Recalling Organisation: | Bio-Rad New Zealand Level 30 48 Shortland Street AUCKLAND 1010 |
| Contact Information: | 0508 805 500 |
| Manufacturer: | Bio-Rad Laboratories Inc |
| Issue: | In case of non interpretable results in the anti-AB well (ABO3) of ID-cards intended for ABO forward grouping, the IH-Com software does not include the reaction of this well (result code-30) wheh sending the result to the laboratory Host. The issue can only occur if the following conditions are met: 1. IH-Com Software is connected to the laboratory Host through ASTM communication mode and, 2. an "ABO not interpretable" result is obtained due to a reaction "?" or "+/-" or "dp" in the anti-ABWell of an ID-Card ** intended forABO forward grouping and 3. the "Second reading" option is deactivated and IN-Com results are directly sent to the Host, or 4. The "Second reading" option is activated but the "not interpretable" result obtained in IH-Com is directly saved and sent to the Host without a manual selection by the user in ABO scrollbar |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/12/2012 |
